KLK2

Johnson & Johnson's targeted alpha therapy JNJ-6420 demonstrated potentially encouraging anti-tumour effects in heavily pretreated men with metastatic castration-resistant prostate cancer, according to new early-stage trial data to be presented at the upcoming American Society of Clinical Oncology (ASCO) annual meeting.However, while the company's foray into the radiopharmaceutical space was marked by promising efficacy, the first-in-human Phase I study of JNJ-6420 – which targets human kallikrein 2 with an actinium-225 (225Ac)-labeled antibody – was also marred by four patient deaths considered related to treatment.Among 57 patients treated at dose levels of ≥150 µCi of JNJ-6420, 45.6% saw their prostate-specific antigen levels decline by at least half (PSA50), while 14% achieved PSA90. Researchers also noted that JNJ-6420 elicited "profound and durable biochemical and radiographic responses" after one or two doses of the experimental therapy. The confirmed objective response rate was 12.5% among the 24 patients with measurable disease at baseline, including one complete reponse and two partial responses.ILD, thrombocytopenia key adverse eventsHowever, the flip side of the JNJ-6420 data revealed treatment-related toxicities, including thrombocytopenia and interstitial lung disease (ILD), which researchers said were both associated with repeated dosing. Rates of thrombocytopenia and ILD were 63.2% and 9%, respectively. Investigators noted that all five ILD cases occurred at cumulative doses of ≥500 µCi and prior to implementation of pulmonary function surveillance.Overall, 61.4% of patients treated with 150 µCi of JNJ-6420 or more experienced Grade ≥3 treatment-emergent adverse events, which aside from thrombocytopenia and ILD also included anaemia, lymphopenia and leukopenia. In addition, nine out of 57 patients (15.8%) discontinued treatment due to toxicities related to JNJ-6420.Johnson & Johnson is the latest company jumping into the increasingly busy radiopharmaceutical space, which has seen a spate of recent deals, including Eli Lilly inking one just this week for Aktis Oncology to the tune of up to $1.1 billion. For related analysis, see Vital Signs: Mapping the slim pickings in radiopharmaceuticals.ASCO Daily Digest – your go-to-source for the key developments emerging from this year's American Society of Clinical Oncology (ASCO) annual meeting. Exclusively for PLUS subscribers – sign up here!

SAN DIEGO, Oct. 05, 2022 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today announced that the Company will present clinical and preclinical data for the Company’s induced pluripotent stem cell (iPSC) product platform at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held in Boston, MA, and virtually, November 8-12, 2022. Details of the SITC poster presentations are as follows: Clinical Programs Combining FT536, a pan-tumor targeting CAR NK cell therapy, with CD16 engagers provides a coordinated targeting strategy to overcome tumor heterogeneity Date and Time:November 11, 2022, 9:00 AM – 9:00 PM Abstract ID:204 Interim Phase I clinical data of FT538, an off-the-shelf, multiplexed-engineered, iPSC-derived NK cell therapy, combined with monoclonal antibodies in patients with advanced solid tumors Date and Time:November 10, 2022, 9:00 AM – 9:00 PM Abstract ID:727 Phase I results of FT516, an off-the-shelf, iPSC-derived NK cell therapy expressing a high-affinity, non-cleavable CD16 (hnCD16) combined with avelumab in patients with advanced solid tumors Date and Time:November 11, 2022, 9:00 AM – 9:00 PM Abstract ID:726 Results of a Phase I trial of FT500, a first-in-class, off-the-shelf, iPSC‑derived NK cell therapy combined with PD-1/PD-L1 checkpoint blockade therapy and IL-2 in patients with advanced solid tumors Date and Time:November 10, 2022, 9:00 AM – 9:00 PM Abstract ID:755 Preclinical Programs Targeting cold tumors using iPSC-derived CAR-T cells directed to the immune checkpoint molecule and tumor-associated antigen B7-H3 Date and Time:November 11, 2022, 9:00 AM – 9:00 PM Abstract ID:288 Off-the-shelf iPSC-derived CAR-T cells targeting KLK2 demonstrate prolonged tumor control and survival in xenograft models of prostate cancer Date and Time:November 11, 2022, 9:00 AM – 9:00 PM Abstract ID:326 Off-the-shelf iPSC-derived CAR-T cells containing seven functional edits overcome antigen heterogeneity, improve trafficking and withstand immunosuppression associated with failed tumor treatment Date and Time:November 11, 2022, 9:00 AM – 9:00 PM Abstract ID:304 iPSC Product Platform Engineering of synthetic chemokine receptors into iPSC-derived CAR-T cells to increase homing and enhance trafficking into solid tumors Date and Time:November 11, 2022, 9:00 AM – 9:00 PM Abstract ID:276 iPSC-derived NK cells engineered with a novel TGFβ signal redirector receptor exhibit enhanced performance against solid tumors Date and Time:November 10, 2022, 9:00 AM – 9:00 PM Abstract ID:259 Tri-modal CAR+TCR+hnCD16+ iPSC-derived T cells co-targeting surface and intracellular/neoantigens demonstrate additive effect on overcoming tumor heterogeneity and cancer escape Date and Time:November 11, 2022, 9:00 AM – 9:00 PM Abstract ID:300 Novel immune reconstitution model highlights the importance of stealth strategies that potentiate effector cell function and promote functional persistence of next-generation adoptive cell therapies Date and Time:November 10, 2022, 9:00 AM – 9:00 PM Abstract ID:341 Preclinical in vivo model development: Highlighting success and discussing xenograft advancements, a step closer in predicting patient outcomes Date and Time:November 10, 2022, 9:00 AM – 9:00 PM Abstract ID:279 About Fate Therapeutics’ iPSC Product PlatformThe Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications. About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's product candidates, clinical studies and preclinical research and development programs, its ongoing and planned clinical studies, and the safety and therapeutic potential of the Company’s product candidates. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s product candidates may not demonstrate the requisite safety or efficacy to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that the Company’s product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com